An Accelerated Access Pathway for Innovative High-risk Medical Devices under the new European Union Medical Devices and Health Technology Assessment Regulations? Analysis and Recommendations.

Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed that can fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre-, post-market), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.